Pediatric Mechanical Circulatory Support (MCS)
Ivan Wilmot, MD
Heart Failure, Transplant, MCS
Assistant Professor
The Heart Institute
Cincinnati Children’s Hospital Medical Center
The University of Cincinnati College of Medicine
Disclosures
- None
- Off-label use of FDA approved adult devices will be discussed
Pediatric Heart Failure
- Children with heart failure refractory to medical therapy have very limited therapeutic options
- Traditionally, such children were listed for heart transplantation with hopes to support them adequately to heart transplant
- Extracorporeal membranous oxygenation (ECMO), although used in the past as bridge to transplant (BTT), has been associated with poor outcomes
Survival on ECMO as bridge to transplant and to discharge (1994-2009)
Almond C S et al. Circulation 2011
Post transplant survival of patients bridged to transplant on ECMO
Almond C S et al. Circulation 2011
Pediatric Heart Failure
- In contrast to adults with HF, children with HF vary in size, anatomy (congenital heart disease), and total number.
- As the pediatric population living with HF expands, increasing demands on alternatives to ECMO have arisen.
- These factors pose significant technological and financial concerns on the development of alternative forms of Mechanical Circulatory Support (MCS) for children with HF.
MCS
- Mechanical Circulatory Support (MCS) is the use of a mechanical pump/s to support a weakened heart muscle.
- Ventricular Assist Device (VAD) to assist a
weakened ventricle
- Total Artifical Heart (TAH) to replace
biventricular failing heart
MCS
- Mechanical Circulatory Support (MCS) can be used in the following roles:
- Bridge to Transplant (BTT)
- Bridge to Recovery (BTR)
- Bridge to Decision/Candidacy (BTD)
- Chronic Therapy
MCS
- Mechanical Circulatory Support (MCS) can be used in the following roles:
- Bridge to Transplant (BTT)
- Bridge to Recovery (BTR)
- Bridge to Decision/Candidacy (BTD)
- Chronic Therapy
MCS
- The EXCOR Berlin Heart IDE FDA study from July, 2011 compared outcomes in both infants & toddlers (BSA < 0.7, cohort 1), and children (BSA 0.7-1.5, cohort 2) managed on
- ECMO vs. VAD
- Uni - or Bi- Ventricular Support
- Longest application > 1000 days
- Wide selection of blood pumps and cannulas
- Specially designed small pumps and cannulas for infants and children
- Easy visual inspection of the blood pumps (pump performance and/or deposit formation)
- Paracorporeal design allows for ease of exchange due to upsize or thrombus
EXCOR Berlin Heart
EXCOR® Device Description
Paracorporeal ventricular assist device (VAD)
10 ml 60 ml50 ml25 ml 30 ml
ArterialApicalAtrial
IKUS® driving unit
®
EXCOR Berlin Heart
• EXCOR® Ikus Driving Unit
– Electro pneumatic driving unit
– Suitable for all EXCOR® blood pumps
– Uni- and biventricular operation
– Battery back-up
– Hand pump provided for emergency use
– Various operating modes for BVAD support
EXCOR Berlin Heart
EXCOR Berlin Heart IDE Outcomes
Fraser et al NEJM 2012
EXCOR Berlin Heart IDE Outcomes
Trial Results: Cohort 1 Patient Status
®
21/24 21/24
0 0
8/207/20
13/20
3/20
6/204/12
3/12
9/12
3/12
4/12
0
10
20
30
40
50
60
70
80
90
100
Sedated Intubated Awake Ambulating Eating
Pe
rce
nt
Pre-implant 2 Weeks 1 Month
3/24
Note: median age of this cohort is 12 months
EXCOR Berlin Heart IDE Outcomes
Trial Results: Cohort 2 Patient Status
16/24
14/24
12/24
5/24
8/246/20
6/20
14/20
4/20
12/20
5/17 5/17
13/17
8/17
9/17
0
10
20
30
40
50
60
70
80
90
100
Sedated Intubated Awake Ambulating Eating
Pe
rce
nt
Pre-implant 2 Weeks 1 Month
®
MCS
- EXCOR Berlin Heart IDE study led to FDA approval of the device in U.S.A. on December 16, 2011
- Although this study showed a significant mortality benefit, significant morbidity remained
- Bleeding 44%
- Stroke 29%
MCS
- Mechanical Circulatory Support (MCS) can be used in the following roles:
- Bridge to Transplant (BTT)
- Bridge to Recovery (BTR)
- Bridge to Decision/Candidacy (BTD)
- Chronic Therapy
MCS
- Mechanical Circulatory Support (MCS) can be used in the following roles:
- Bridge to Transplant (BTT)
- Bridge to Recovery (BTR)
- Bridge to Decision/Candidacy (BTD)
- Chronic Therapy
MCS
- This retrospective study evaluated MCS in the management of patients with acute fulminant myocarditis and persistent myocarditis from 1995 to 2009 at Texas Children’s Hospital, Houston, TX
- MCS included ECMO and/or VAD
- Primary outcome measures: Bridge to recovery (BTR), Bridge to transplant (BTT), or death
Wilmot et al. J Car Fail. 2011
MCS
– Details of MCS
• Temporary mechanical circulatory support was provided using: ECMO or short-term VAD
• Short-term VADs: BioMedicus Biopump®, Rotoflow®, Tandem Heart®
• Long-term VADs: MicroMed DeBakey VAD Child, Thoratec VAD, HeartMate II LVAD
Wilmot et al. J Car Fail. 2011
TandemHeart®
Percutaneous placed
short-term LVAD
Courtesy of Cardiac Assist Inc, Pittsburg, PA
HeartMate II LVAD
Surgically placed long-term
LVAD
Courtesy of Thoratec Corp., Pleasanton, CA
Battery pack
External console
MCS in Children with Myocarditis Outcomes
Wilmot et al. J Car Fail. 2011
MCS in Children with Myocarditis Outcomes
Wilmot et al. J Car Fail. 2011
44% BTR
67% ECMO Survival
80% VAD Survival
MCS
- Increasing literature reports show promising
VAD results in the pediatric HF population.
- In the setting of limited heart transplant
donors, and increasing numbers of children
with HF, many centers are utilizing VAD’s as
a bridge to transplant (BTT).
Chen et al. Eur J Cardiothorac Surg 2005
Lorts et al. Curr Opin Organ Transplant 2015
Increased Number of Participating Centers in PediMACS
Blume et al-AHA 2014
ISHLT BTT with MCS (2004-2013)
ISHLT. 2013
% patients BTT with MCS
MCS
- With the increased utilization of MCS in the
pediatric HF population, the ISHLT recently
released updated Guidelines for the
Management of Pediatric HF in 2014.
- These guidelines include MCS use in the
pediatric HF population including indications
for MCS, patient selection, timing of implant,
device selection, and recommendations.
ISHLT Guidelines for the Management of Pediatric Heart Failure, 2014
MCS
- MCS is reserved for children with acute life-
threatening cardiovascular events or severe
HF symptoms despite maximal medical
therapy.
- MCS should be considered if a child requires
inotropic infusions to maintain cardiovascular
stability and other organ systems begin to be
compromised.
ISHLT Guidelines for Management of Pediatric Heart Failure, 2014
ISHLT Guidelines Pediatric MCS Protocol
ISHLT Guidelines for the Management of Pediatric Heart Failure, 2014
MCS
- Mechanical Circulatory Support (MCS) can be used in the following roles:
- Bridge to Transplant (BTT)
- Bridge to Recovery (BTR)
- Bridge to Decision/Candidacy (BTD)
- Chronic Therapy
MCS
- Mechanical Circulatory Support (MCS) can be used in the following roles:
- Bridge to Transplant (BTT)
- Bridge to Recovery (BTR)
- Bridge to Decision/Candidacy (BTD)
- Chronic Therapy
Special Pediatric MCS Considerations
- An increased interest in chronic therapy for pediatric patients
– Muscular dystrophy
– Cancer patients post chemotherapy
– Patients with contraindications to transplant (elevated pulmonary vascular resistance)
MCS
- DMD patient implanted with HeartWare LVAD
MCS
-Transplant patient with chronic
rejection and subsequent
Syncardia TAH placement as
BTT
Conclusions
- Although children with HF refractory to medical therapy have limited options, recent advances in MCS can provide superior outcomes when used as a bridge to transplant (BTT).
- The Berlin Heart EXCOR VAD provide a MCS option for both infants and children, however morbidity concerns remain.
- MCS can be used successfully as a bridge to transplant (BTT), bridge to recovery (BTR), and bridge to decision (BTD).
Conclusions
- 2014 ISHLT Guidelines for the Management
of Pediatric HF include indications for MCS,
patient selection, timing of implant, device
selection, and recommendations.
- There is an increasing interest in MCS as a
chronic therapy in pediatrics.
- The future of MCS in children appears
promising with increasing options available
in this vulnerable population
Acknowledgements
David Morales, MD
Rosevelt Bryant III, MD
Angela Lorts, MD
Chet Villa, MD
Aimee Gardner
Amanda Schubert
Thank You
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